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A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability
Sponsor: Egoo Health Aps
Summary
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). This home monitor is intended to be an adjunct to current clinical practice in the management of individuals with PKU. The objective of this investigation is to perform multi blood comparison studies between the Egoo Phe System and the standard analytical methods (finger prick blood spots) to demonstrate the Egoo Phe System's accuracy.
Official title: Egoo Phe System - A Blood Phenylalanine Self-Test Measuring System
Key Details
Gender
All
Age Range
Any - 3 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2025-04-15
Completion Date
2025-10-31
Last Updated
2025-04-23
Healthy Volunteers
No
Conditions
Locations (1)
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom